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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device system, therapeutic, x-ray
Regulation Description X-ray radiation therapy system.
Product CodeJAD
Regulation Number 892.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT 1
NUCLETRON B.V.
  SUBSTANTIALLY EQUIVALENT 1
XSTRAHL LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 5 5
2023 2 2
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Patient Device Interaction Problem 2 2
Insufficient Information 1 1
Unexpected/Unintended Radiation Output 1 1
Use of Device Problem 1 1
Device Operational Issue 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Integrity Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Radiation Burn 3 3
Pain 3 3
Insufficient Information 3 3
Tissue Breakdown 2 2
Unspecified Vascular Problem 2 2
Ulcer 2 2
Hair Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sensus Healthcare, Inc. II Mar-08-2023
2 Xstrahl Limited II Dec-16-2021
3 Xstrahl Limited II Oct-26-2021
4 Xstrahl Limited II Jul-19-2022
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